Gatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a potential quality/potency issue identified through routine stability testing, making it a precautionary recall appropriate for a Moderate severity score.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottles (NDC 68180-435-01) distributed nationwide in the USA and Puerto Rico. The recall affects three lots: H003037 (exp. May 2022), H100132 (exp. June 2022), and H100847 (exp. October 2022).
The manufacturer observed out-of-specification results in a water loss test. This test failure might affect the assay content and alter the drug concentration in the product.
Patients who have this medication should contact their healthcare provider or pharmacist. Do not stop using the medication without speaking to a healthcare professional first, as doing so could affect treatment. Return unused product to the pharmacy for proper disposal.
The recalled product
- Product
- Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Affected units
- 50,832
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot #: H003037
- exp. date May 2022
- H100132
- exp. date June 2022
- H100847
- exp. date October 2022
Distribution
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